DXA-INPUT-OUTPUT-DEC

Additional Manufacturer Narrative

WHEN TIGHTENING THE LOCK NUT TO THE ANALYZER FEET, FSE WAS INJURED WITH LACERATION ON THE RIGHT WRIST. THE FSE VISITED THE EMERGENCY ROOM AND RECEIVED TREATMENT. THE FSE EVALUATED THE ANALYZER AND FOUND NO EVIDENCE OF A HARDWARE MALFUNCTION. BASED ON THE AVAILABLE INFORMATION SUGGESTS THIS WAS AN ACCIDENTAL INJURY. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).

Description of Event or Problem

THE BECKMAN FIELD SERVICE ENGINEER (FSE) REPORTED A LACERATION ON THE RIGHT WRIST DURING AN INSTALLATION OF THE DXA ANALYZER. THE INCIDENT OCCURRED WHEN FSE WAS TIGHTENING THE LOCKNUT WITH A WRENCH AND THE WRENCH SLIPPED. THE FSE WAS WEARING GLOVES AT THE TIME OF THE INJURY. THE FSE APPLIED A BAND-AID TO STOP THE BLEEDING AND WENT TO EMERGENCY ROOM FOR TREATMENT OF THE LACERATION. THE FSE WAS NOT PRESCRIBED ANY MEDICATION AND DID NOT MISS ANY WORK DUE TO THE INJURY. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

UPON ADDITIONAL REVIEW, IT WAS DETERMINED THE BECKMAN FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND FOUND NO EVIDENCE OF BECKMAN ANALYZER MALFUNCTION. NO HARDWARE PARTS WERE REPLACED. THE REPORTED INJURY WAS A RESULT OF A WRENCH HITTING THE RIGHT-HAND WRIST. BASED ON THE AVAILABLE INFORMATION SUGGESTED THIS EVENT WAS AN ACCIDENTAL INJURY. THE FSE REPORTED NO FURTHER ISSUES DUE TO THE EVENT. THIS IS NOT A REPORTABLE EVENT.